FDAHealthSeptember 29, 2025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

⚠️ Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

Is this relevant to me?

Geography: US, MO, TX
Source agency: FDA
Category: Health
Published: September 29, 2025

Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.

What's affected?

Product: Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Lot code: Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

Additional details

Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 29 units.

View original FDA notice →

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